gudid
Primary ID: 89101
AccuHome Pregnancy Test (UDI 89101)
Manufactured by GERMAINE LABORATORIES, INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AccuHome Pregnancy Test - Primary ID 89101
Device Regulatory Overview
The AccuHome Pregnancy Test (Model/Catalog Number: 89101) is a medical device manufactured by GERMAINE LABORATORIES, INC. This product is indexed under FDA Product Code / Category Classification DHA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 89101
- Product Code / EMDN
- DHA
- Device Name
- Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for self testing (home). Results within 3 minutes.
- Database Sync Date
- 2026-08-09 09:04:20
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of AccuHome Pregnancy Test?
The registered manufacturer of record for AccuHome Pregnancy Test is GERMAINE LABORATORIES, INC.
What is the Primary UDI-DI identifier for AccuHome Pregnancy Test?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 89101.
What classification code is assigned to this device?
This device is registered under product classification code DHA.
Similar Classification Devices (DHA)
Other Devices by GERMAINE LABORATORIES, INC
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